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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00359229 |
Primary objective:
1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China
Secondary objectives:
Condition | Intervention | Phase |
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Insomnia |
Drug: Zolpidem |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre Prospective, Open Label ,3 Weeks Phase IV Study to Evaluate the Efficacy and Safety in Elder Patients With Insomnia in China |
Enrollment: | 115 |
Study Start Date: | July 2006 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
For 3 weeks
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Drug: Zolpidem
Administration of Zolpidem 5mg
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | ZOLPI_L_01540 |
Study First Received: | July 31, 2006 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00359229 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Zolpidem Sleep Initiation and Maintenance Disorders Neurotransmitter Agents Mental Disorders GABA Agonists |
Hypnotics and Sedatives Central Nervous System Depressants Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Zolpidem Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Dyssomnias Sleep Disorders |
Pharmacologic Actions Sleep Disorders, Intrinsic Mental Disorders Therapeutic Uses GABA Agonists Hypnotics and Sedatives GABA Agents Central Nervous System Agents |